IRT Project Manager
Remote from anywhere in the U.S. or Canada
- Responsible for IRT system initial implementation, maintenance, and closure.
- Ensure comprehensive understanding of requirements and design to provide quality deliverables.
- Organizes kick-off meeting and team meetings.
- Coordinates review and sign-off of requirements and release documents.
- Directs teams during development and testing for initial implementation and updates.
- Reviews and Approves UAT documentation
- Manages post-production change controls.
- Facilitates database lock activities with study team, vendor, and other stakeholders. Coordinates decommissioning and archiving.
- Advise the team and stakeholders, informing on the processes that will be completed to enable system implementation and updates.
- Minimum 3-5+ years of experience in clinical systems such as CTMS, ePRO, IXRS, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Strong oral and written communication skills. Experienced project leader and presenter.
- Able to work both independently and collaboratively across multiple functional areas.
- Proficiency in understanding complex business requirements and communicating those to technical and project teams.
- Understanding of Drug Development and Clinical Trial Processes
- Understanding of Data Management Processes
- In-depth knowledge of Good Clinical Practices
- Understanding of Clinical Research System Development Lifecycle
- Must have sound problem resolution, judgement and decision-making skills.
- Ability to prioritize tasks effectively and manage multiple projects simultaneously.